An Overview of Edurant (Rilpivirine)

Brand Name: Edurant
Other Name(s): R278474, Rilpivirine hydrochloride, TMC278
Drug Class: Non-nucleoside Reverse Transcriptase Inhibitors

Rilpivirine, also known as Edurant, is a type of medicine called a non-nucleoside reverse transcriptase inhibitor (NNRTI). Rilpivirine works by disrupting one of the early steps in the HIV life cycle, called reverse transcription. During normal reverse transcription, HIV's reverse transcriptase enzyme (a type of protein) converts HIV's RNA -- a single strand of genetic information -- into DNA -- a double strand of genetic information. It does this by recoding the RNA building blocks into complementary DNA building blocks. As the HIV life cycle proceeds, the newly formed DNA is used to make more copies of HIV virus.

When rilpivirine is present, however, it attaches directly to reverse transcriptase, blocking the conversion of RNA into DNA. This process prevents virus replication and halts the HIV life cycle.

Indications and Usage

Rilpivirine was approved by the U.S. Food and Drug Administration (FDA) on May 20, 2011, for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults who have not taken HIV medicines before (treatment-naive adult patients).

Rilpivirine does not cure or prevent HIV infection or AIDS and does not reduce the risk of passing the virus to other people.

Dosage Form/Administration

Always take this medication as your doctor instructs. Rilpivirine tablets are taken by mouth with food (a meal), and rilpivirine is always used in combination with other anti-HIV medications.

Dosage forms and strengths

• Tablets: 25 mg

What storage conditions are needed for this medication?

• Store rilpivirine between 59°F and 86°F (15°C to 30°C)

Keep this medication in the container it came in, tightly closed, and out of reach of children. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

• Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
• It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking -- as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Recommended Daily Dose

• The usual recommended adult dosage of rilpivirine is one 25 mg tablet taken once daily by mouth and with a meal.
• Depending on certain factors, dosage adjustments may be necessary. Always take rilpivirine exactly as prescribed by your doctor.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Contraindications

What special precautions should I follow?

Before taking rilpivirine,

• Tell your doctor and pharmacist if you are allergic to rilpivirine or any other medications.
• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
• Note that rilpivirine must not be used if you are taking certain other medicines (see Drug Interactions).
• Tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking rilpivirine, call your doctor. Tell your doctor if you are breastfeeding. You should not breastfeed if you are infected with HIV or if you are taking rilpivirine.
• Tell your doctor about any medical problems you may have had or currently have, including liver problems (such as hepatitis B or C) or mental health problems.

Possible Side Effects

Rilpivirine may cause side effects.

The following life-threatening or serious side effects have been reported. Contact your doctor immediately if you experience:

• Depression or Mood Changes. Let your doctor know right away if you develop any of the following symptoms:
  • feeling sad or hopeless
  • have thoughts of hurting yourself (suicide) or have tried to hurt yourself
  • feeling anxious or restless
• Changes in Body Fat. Changes may include an increased amount of fat in the upper back and neck (buffalo hump), chest, and around the middle of your body (trunk). Loss of fat from the legs, arms, and face may also occur. The exact cause and long-term health effects of these problems are not known.
• Changes in your Immune System (Immune Reconstitution Syndrome). This can occur when you start HIV medicines. As your immune system becomes stronger, your body may begin to fight infections that have been "hidden" in your body for a long time. Call your doctor immediately if you start having any new symptoms after starting your HIV medicine.

Common side effects that may be associated with rilpivirine include the following. Let your doctor know if any of these side effects do not go away or worsen:

• trouble sleeping (insomnia)
• headache
• rash

Rilpivirine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the U.S. FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088.

Drug Interactions

Rilpivirine may interact with other medicines. Before taking rilpivirine, it is important to tell your doctor about any prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

You should not take rilpivirine with the following medicines:

• the anti-seizure medicines carbamazepine, oxcarbazepine, phenobarbital, and phenytoin
• the anti-TB medicines rifabutin, rifampin, and rifapentine
• proton pump inhibitor (PPI) medicines for certain stomach or intestinal problems, including esomeprazole, lansoprazole, omeprazole, pantoprazole sodium, and rabeprazole
• more than one dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate
• St. John's wort (Hypericum perforatum)

Other medicines that may interact with rilpivirine and should be used with caution include the following:

• antacid medicines that contain aluminum, magnesium hydroxide, or calcium carbonate. Take antacids at least 2 hours before or at least 4 hours after you take rilpivirine.
• histamine-2 blocker medicines, including famotidine, cimetidine, nizatidine, and ranitidine hydrochloride. Take these medicines at least 12 hours before or at least 4 hours after you take rilpivirine.
• antibiotic medicines clarithromycin, erythromycin, and troleandomycin
• antifungal medicines taken by mouth, including fluconazole, itraconazole, ketoconazole, posaconazole, and voriconazole
• methadone

In addition to the lists above, there are other medicines that may interact with rilpivirine. For a complete list of all medicines that may interact with rilpivirine, talk with your doctor or pharmacist and check the manufacturer's Web site for the full prescribing information.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet. Rilpivirine should always be taken with food (a meal).

Clinical Trials

Click here to search ClinicalTrials.gov for trials that use Rilpivirine.

Manufacturer Information

Edurant
Tibotec Therapeutics
1125 Trenton-Harbourton Road
Titusville, NJ 08560
Phone: 1-877-REACH-IT (1-877-732-2488)

Rilpivirine
Tibotec Therapeutics
1125 Trenton-Harbourton Road
Titusville, NJ 08560
Phone: 1-877-REACH-IT (1-877-732-2488)